The Food and Drug Administration has given the green light to Moderna’s latest Covid-19 vaccine, mNexspike, with certain restrictions in place. Unlike its predecessor, Spikevax, the new vaccine will not immediately replace it, as both will be available on the market for the time being.
Moderna CEO Stéphane Bancel expressed the importance of this new tool in protecting individuals at high risk of severe Covid-19. The FDA approval specifies that mNexspike is licensed for use in individuals aged 65 and older, as well as those aged 12 to 64 with specific medical conditions that increase their risk of severe illness from the SARS-CoV-2 virus.
In contrast, Spikevax is approved for individuals aged 12 and older. The FDA’s decision on the new Moderna vaccine was reached on the agreed-upon date of May 31, in contrast to the delayed decision on the Novavax vaccine.
Despite the approval, Moderna faced skepticism regarding mRNA-based vaccines from individuals such as health secretary Robert F. Kennedy Jr. and his supporters. The Department of Health and Human Services recently canceled contracts with Moderna for the development of prototype vaccines against potential pandemic-causing influenza subtypes, citing concerns about the safety record of mRNA technology.
However, mRNA-based vaccines, including those from Pfizer-BioNTech and Moderna, have been widely administered globally with minimal reported side effects. The new mNexspike vaccine utilizes a refined target to generate antibodies against the SARS-CoV-2 virus, allowing for a smaller dosage compared to Spikevax.
Moderna has been instructed by the FDA to conduct post-marketing studies on mNexspike, including an observational study on pregnant individuals who receive the vaccine. This study may face challenges following Kennedy’s decision to remove recommendations for healthy children and pregnant individuals to receive the Covid vaccine.
The FDA’s approval letter also requires Moderna to conduct a randomized controlled trial on adults aged 50 to 64 to assess the continued benefits of Covid vaccination in this group. FDA Commissioner Marty Makary and vaccines division head Vinay Prasad have emphasized the need to target vaccine use to high-risk groups and individuals aged 65 and older in the future.
Overall, the approval of Moderna’s mNexspike vaccine represents a significant step in the ongoing battle against Covid-19, providing an additional tool to protect vulnerable populations from severe illness.
